Regulatory Strategies
Accelerate product development, mitigate regulatory risks, & optimize product manufacturing & controls by leveraging the extensive breadth & depth of regulatory experience & leadership at NGT BioPharma Consultants
NGT regulatory experts have decades of extensive experience in development and global regulatory approvals of all types of small and large molecule product modalities including devices. NGT regulatory consultants provide clients with CMC and clinical development strategies toward the most expeditious path to approval.
Services
Our regulatory consultants collaborate seamlessly with Nonclinical, Clinical, CMC, and Quality/Compliance teams to address global regulatory and quality issues.
NGT consultants develop comprehensive regulatory strategies, manage agency interactions, and prepare documentation for investigational, commercial, and post-approval applications throughout the product lifecycle.
We offer project management support and a ‘single point of contact’ interface with publishing vendors and CRO’s.
NGT regulatory capabilities include, but are not limited to, the following specific services:
- IND/CTA submission support including clinical study protocols and CMC, pharmacology & toxicology information
- Prepare companies for Pre-NDA meetings
- Create and manage Emergency Use Authorizations submissions
- Provide NDA/BLA/MAA dossier authoring and regulatory project management
- Facilitate expedited program requests (Breakthrough, Fast Track, Priority Review, Accelerated Approval)
- Manage responses to health authority questions
- Serve as U.S. Agent for non-U.S. entities
- Provide regulatory due diligence, gap analyses and risk management
- Offer guidance on rare pediatric disease designations
- Support Special Protocol Assessments (SPA’s)
- Prepare requests for Orphan Drug Designation
- Provide regulatory strategy refinement and optimization
PRECLINICAL AND CLINICAL DRUG DEVELOPMENT
- Assess IND-enabling studies for submission readiness
- Establish a local or global regulatory strategies, including plans for leveraging expedited pathways and special programs
- Optimize, create and submit meeting requests, meeting packages and briefing books
- Provide IND and CTA maintenance (initial submissions, amendments, annual and periodic reports and closure
REGISTRATION
- Prepare companies for Pre-NDA meetings and scientific advice
- Create and manage Emergency Use Authorizations submissions
- Provide NDA/BLA/MAA dossier authoring and regulatory project management
- Priority review requests
- Managing responses to health authority questions
ADDITIONAL SERVICES
- U.S. Agent for non-U.S. entities
- Regulatory due diligence, gap analyses and risk management
- Rare Pediatric Disease Designations
- Special Protocol Assessments
- Expedited program requests (Breakthrough, Fast Track, Priority Review, Accelerated Approval)
- Orphan Drug Designations
- Regulatory strategy refinement and optimization
NGT BioPharma Consultants provides project management services and works closely with a network of submission publishing companies to manage global e-submissions
Working with Big Pharma Globally
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Get in touch
For additional information pertaining to the service area Regulatory Strategies please contact Roger or our CEO Michael O'Brien via the contact information provided below. Alternatively, please fill out the form and we will get back to you within 48 hours.
